A Study to Investigate the Effect of PH-797804 on QTc Interval

A Phase 1, Randomized, Placebo-And Positive-Controlled Crossover Study To Determine The Effect Of A Single-Dose Of PH-797804 On QTc Interval In Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01862887

Enrollment

Registered

2013-05-27

Start date

2013-04-30

Completion date

2013-08-31

Last updated

2013-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The purpose of this study is to investigate the effect of PH-797804 following dosing of a 24 mg oral tablet on the QTc interval

Interventions

DRUGPH-797804

Tablet, 24 mg, single dose

DRUGMoxifloxacin

Tablet, 400 mg, single dose

DRUGPlacebo

Tablet, PH-797804 matched placebo, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \> 50 kg (110 lbs).

Exclusion criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * A positive urine drug screen. * History of regular alcohol consumption exceeding 14 drinks/week for males.

Design outcomes

Primary

Measure	Time frame	Description
QTcF Interval	-1.5,-1,-0.5,0.5,2,4,5,6,7,8,12,24 hours post-dose	QT interval corrected for heart rate using Fredericias correction

Secondary

Measure	Time frame	Description
QTcI Interval	-1.5,-1,-0.5,0.5,2,4,5,6,7,8,12,24 hours post-dose	QT interval using individual heart rate correction
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]	0,0.5,2,4,5,6,7,8,12,24 hours post-dose	AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Maximum Observed Plasma Concentration (Cmax)	0,0.5,2,4,5,6,7,8,12,24 hours post-dose	—
Time to Reach Maximum Observed Plasma Concentration (Tmax)	0,0.5,2,4,5,6,7,8,12,24 hours post-dose	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026